SAN DIEGO, June 21, 2021 /PRNewswire/ -- Inhibrx, Inc.
(Nasdaq: INBX), a biotechnology company with four clinical programs
in development, announced initiation of a potential
registration-enabling Phase 2 study of INBRX-109 in conventional
chondrosarcoma.
INBRX-109 is a precision-engineered, tetravalent death receptor
5 (DR5) agonist antibody designed to exploit the tumor-biased cell
death induced by DR5 activation.
Chondrosarcoma is an orphan bone cancer with approximately 2,800
new patients diagnosed annually in the
United States and the European Union. There are currently no
therapeutics approved for the treatment of chondrosarcoma.
In January 2021, the U.S. Food and
Drug Administration (FDA) granted Fast Track designation to
INBRX-109 for the treatment of patients with unresectable or
metastatic conventional chondrosarcoma.
Inhibrx provided updated results from an ongoing Phase 1
clinical trial evaluating the efficacy and safety of INBRX-109 in
patients with conventional chondrosarcoma. Additional data will be
presented at the Annual Connective Tissue Oncology Society (CTOS)
Conference taking place on November 10-13,
2021.
- Disease control was observed in 14 of 16 patients (87.5%). Two
patients (12.5%) achieved partial responses and 12 of 16 patients
(75%) had stable disease measured by RECISTv1.1.
- Based on preliminary results of the ongoing Phase 1 study, the
median progression-free survival (PFS) is 7.6 months, and the
median overall survival has not been reached.
- Three patients have exceeded 52 weeks on treatment with
INBRX-109, with 62 weeks being the longest duration of stable
disease observed to date, with the patient still on study.
- The safety and tolerability profile in conventional
chondrosarcoma was favorable with only 1 out of 16 patients
experiencing a transient low grade and fully reversible sign of
hepatotoxicity.
- The trial is ongoing with an additional 12 slots added for
patients with IDH1 or IDH2 mutations to support ongoing biomarker
discovery efforts.
A randomized, blinded, placebo-controlled, potential
registration-enabling Phase 2 trial of INBRX-109 in conventional
chondrosarcoma initiated this month. The primary objective of this
trial is to evaluate the anticancer efficacy of INBRX-109, as
measured by PFS per RECISTv1.1 and assessed by central independent
radiology review. Patients with disease progression on placebo will
be able to crossover to INBRX-109. An interim analysis will occur
after 50% of the planned PFS events are observed.
Additionally, upon initiation of this study, Inhibrx's loan
agreement with Oxford Finance was amended and $40M in additional principal was received by
Inhibrx on June 18, 2021.
About Inhibrx, Inc.
Inhibrx is a clinical-stage biotechnology company focused on
developing a broad pipeline of novel biologic therapeutic
candidates in oncology and orphan diseases. Inhibrx utilizes
diverse methods of protein engineering to address the specific
requirements of complex target and disease biology, including its
proprietary sdAb platform. Inhibrx has collaborations with bluebird
bio, Bristol-Myers Squibb and Chiesi. For more information, please
visit www.inhibrx.com.
Forward-Looking Statements
Inhibrx cautions you that statements contained in this press
release regarding matters that are not historical facts are
forward-looking statements. These statements are based on Inhibrx's
current beliefs and expectations. These forward-looking statements
include, but are not limited to, statements regarding: Inhibrx's
and its investigators' judgments and beliefs regarding the observed
safety and efficacy to date of its therapeutic candidate,
INBRX-109, discussions with and beliefs regarding future action by
the U.S. Food and Drug Administration, and statements and beliefs
regarding the future clinical development of INBRX-109 including
statements indicating that the Phase 2 trial is
registration-enabling and the presumption of positive results from
Phase 1 clinical trials. Actual results may differ from those set
forth in this press release due to the risks and uncertainties
inherent in Inhibrx's business, including, without limitation,
risks and uncertainties regarding: the initiation, timing, progress
and results of its preclinical studies and clinical trials, and its
research and development programs; its ability to advance
therapeutic candidates into, and successfully complete, clinical
trials; its interpretation of initial, interim or preliminary data
from its clinical trials, including interpretations regarding
disease control and disease response; the timing or likelihood of
regulatory filings and approvals; the successful commercialization
of its therapeutic candidates, if approved; the pricing, coverage
and reimbursement of its therapeutic candidates, if approved; its
ability to utilize its technology platform to generate and advance
additional therapeutic candidates; the implementation of its
business model and strategic plans for its business and therapeutic
candidates; its ability to successfully manufacture therapeutic
candidates for clinical trials and commercial use, if approved; its
ability to contract with third-party suppliers and manufacturers
and their ability to perform adequately; the scope of protection it
is able to establish and maintain for intellectual property rights
covering its therapeutic candidates; its ability to enter into
strategic partnerships and the potential benefits of these
partnerships; its estimates regarding expenses, capital
requirements and needs for additional financing and financial
performance; its expectations regarding the impact of the COVID-19
pandemic on its business; and other risks described in Inhibrx's
filings with the U.S. Securities and Exchange Commission (the
"SEC"), including under the heading "Risk Factors" in Inhibrx's
Annual Report on Form 10-K for the year ended December 31,
2020, as filed with the SEC. You are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof, and Inhibrx undertakes no obligation to update
these statements to reflect events that occur or circumstances that
exist after the date hereof. All forward-looking statements are
qualified in their entirety by this cautionary statement, which is
made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. This press release contains
estimates and other statistical data made by independent parties
and by Inhibrx. This data involves a number of assumptions and
limitations, and you are cautioned not to give undue weight to such
estimates.
Investor and Media Contact:
Kelly Deck, CFO
kelly@inhibrx.com
858-795-4260
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